Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-04-14 @ 9:20 AM
Study NCT ID:
NCT02297620
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2014-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients
Sponsor:
Astellas Pharma Inc
Organization:
Study Overview
Official Title:
Specified Drug Use resulTs survEy of IpragLifLozin treAtment in ELDERly type2 Diabetes Patients (STELLA-ELDER)
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STELLA-ELDER
Brief Summary:
The objective of this survey is to confirm the safety of Suglat Tablets when used in the elderly.
Detailed Description:
Elderly patients (65 years or older at the time of first administration) with type 2 diabetes who used Suglat Tablets within 3 months from its launch are included in this study. Followings are measured with the patients.
1. Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors.
2. Investigate the occurrence of urinary tract infection.
3. Investigate the occurrence of adverse drug reactions in patients at a high risk (those who have poorly controlled blood sugar levels, concurrent organic abnormalities in the urinary system, advanced diabetic neuropathy, etc).
4. Investigate the occurrence of adverse drug reactions other than the above.
5. Factors that may possibly influence the safety of Suglat Tablets.
1. Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors.
2. Investigate the occurrence of urinary tract infection.
3. Investigate the occurrence of adverse drug reactions in patients at a high risk (those who have poorly controlled blood sugar levels, concurrent organic abnormalities in the urinary system, advanced diabetic neuropathy, etc).
4. Investigate the occurrence of adverse drug reactions other than the above.
5. Factors that may possibly influence the safety of Suglat Tablets.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: